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Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles

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ClinicalTrials.gov Identifier: NCT03223298
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : September 13, 2018
Sponsor:
Collaborators:
New York Presbyterian Hospital
University of Illinois at Chicago
Allergan
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:

This study aims to determine whether the injection of botulinum toxin A or placebo (unpreserved 0.9% sodium chloride) into the masseter and temporalis muscles provides pain relief and improved jaw function in those who suffer from myofascial pain disorder. The study hypothesis is that botulinum toxin A injection is superior to placebo. The specific research questions are:

  1. Is the injection of botulinum toxin A superior to placebo for the improvement in pain?
  2. Is the injection of botulinum toxin A superior to placebo for the improvement in function or quality of life (QOL)?
  3. Are there any adverse effects that result from injection of botulinum toxin A or placebo into the masseters and temporalis muscles? Limited data exists to support the use of botulinum toxin A in the management of myofascial pain disorder of the masticatory region. Botulinum toxin A is not FDA approved for intra-muscular injection within the masticatory region. Its use in the masticatory region is considered off-label but performed without significant known complications. This study will provide the opportunity to quantitate and qualitate any complications in a large prospective sample of patients.

Condition or disease Intervention/treatment Phase
Pain, Head Pain Syndrome Temporomandibular Disorder Myofascial Pain Syndrome Myofascial Pain Drug: Botulinum toxin type A Drug: 0.9% Sodium Chloride Injection Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study participants will be randomly allocated to one of two treatment arms (injection of botulinum versus placebo). Blocked randomization will be performed at each of the participating sites. They will be stratified based on study site.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Randomization will be carried out by the biostatistics team at Weill Cornell. This will provide assurance that there will be equal patient allocation to both study arms, at each participating site, in the event that the target sample size is not reached. The list will be maintained by the investigational pharmacy. A designated research assistant will be identified at each site to prepare the interventional medication (botulinum versus normal saline). The identity of the agent injected will be unknown to the surgeon as the agent will be drawn up by an assistant in a masked syringe immediately prior to each procedure and labeled with the patient's identifier. Only one assistant at each site will know the identity of the agents during the trial.
Primary Purpose: Treatment
Official Title: Comparison of Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles in the Management of Myofascial Pain Disorder: A Randomized Clinical Trial
Actual Study Start Date : August 31, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Botulinum Toxin Type A
The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive 100 units of reconstituted botulinum toxin A. 37.5 units will be injected into each masseter muscle and 12.5 units into each temporalis muscle. A written post-operative instruction sheet will be provided to all patients.
Drug: Botulinum toxin type A
37.5 units injected into each masseter muscle and 12.5 units into each temporalis muscle
Other Names:
  • Botulinum
  • Botox
  • Allergan
  • Botulinum Toxin A

Placebo Comparator: 0.9% Sodium Chloride Injection
The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive unpreserved 0.9% sodium chloride. A written post-operative instruction sheet will be provided to all patients.
Drug: 0.9% Sodium Chloride Injection
1cc syringe
Other Names:
  • Saline
  • Placebo




Primary Outcome Measures :
  1. Pain [ Time Frame: Pre-intervention, Change at 1 month post-intervention, Change at 2 months post-intervention, Change at 3 months post-intervention ]
    Visual Analog Scale ranging from "no pain" to "pain as bad as it could possibly be"


Secondary Outcome Measures :
  1. Function [ Time Frame: Pre-intervention, Change at 1 month post-intervention, Change at 2 months post-intervention, Change at 3 months post-intervention ]
    Maximum interincisal opening & Jaw Function Limitation Scale

  2. Quality of Life [ Time Frame: Pre-intervention, Change at 1 month post-intervention, Change at 2 months post-intervention, Change at 3 months post-intervention ]
    Short Form 36

  3. Adverse Events [ Time Frame: 1 month post-intervention, 2 months post-intervention, 3 months post-intervention ]
    Any adverse events will be documented



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-65 years of age
  • Ability to give informed consent
  • Myofascial pain of masticatory muscles as defined according to the RDC/TMD criteria
  • Baseline pain measured by the subject ≥3.5/10 on visual analog scale

Exclusion Criteria:

  • Baseline pain measured by the subject <3.5/10 on visual analog scale
  • Central/Neuropathic pain disorder affecting the masticatory muscles
  • Temporomandibular Joint Arthralgia that is more severe than the myofascial pain disorder affecting the masticatory muscles
  • Previous Temporomandibular Joint Surgery
  • Systemic arthropathies
  • Fibromyalgia
  • Allergy to study medications
  • Traumatic injury of masticatory muscles or temporomandibular joint within last 12 months
  • Mandibular fracture within last 12 months
  • Pregnancy or breast feeding
  • Cervical radiculopathy or surgery
  • Prior botox injection in the masticatory muscles
  • Initiation of additional treatment of MPD within the past 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223298


Contacts
Contact: Gwendolyn S Reeve, DMD (212) 746-5175 GSR9001@med.cornell.edu
Contact: Ashley R Graham, BS 646-962-4642 arg2005@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College - NewYork-Presbyterian Hospital Recruiting
New York, New York, United States, 10065
Contact: Gwendolyn S Reeve, DMD    212-746-5175    gsr9001@med.cornell.edu   
Contact: Ashley R Graham, BS    (646) 962-4642    arg2005@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
New York Presbyterian Hospital
University of Illinois at Chicago
Allergan
Investigators
Principal Investigator: Michael Miloro, DDS, MD University of Illinois at Chicago
Principal Investigator: Gwendolyn S Reeve, DMD New York Presbyterian
Principal Investigator: Michael Han, DDS, MD University of Illinois at Chicago

Publications:
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03223298     History of Changes
Other Study ID Numbers: 1607017383
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Weill Medical College of Cornell University:
Myofascial Pain
Myofascial Pain Disorder
Maxillofacial Pain
Masseter Muscle
Temporalis Muscle
Botulinum Toxin

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Myofascial Pain Syndromes
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Fibromyalgia
Headache
Disease
Pathologic Processes
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Joint Diseases
Stomatognathic Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action